Abstract 3187
Background
REGATTA is a phase III trial to compare chemotherapy alone (arm A) and reduction surgery followed by chemotherapy (arm B) for advanced gastric cancer with a single non-curable factor. The trial failed to show superiority of reduction surgery, which could be partially explained by poor compliance of chemotherapy in arm B. This exploratory analysis aims to clarify whether upfront surgery has survival benefit in patients (pts) who could continue chemotherapy for some period, enrolled in REGATTA.
Methods
In REGATTA, 175 pts were assigned to arm A (86 pts) and arm B (89 pts). S-1 80 mg/m2 for 3 weeks and CDDP 60 mg/m2 on day 8 was repeated every 6 weeks. The pts were limited to those for whom chemotherapy was continued at 2, 4, or 6 months after randomization (cohort-2M, cohort-4M, or cohort-6M, respectively) and pts who underwent gastrectomy in arm A were excluded. The overall survival (OS) was defined as the duration from the date at 2, 4, or 6 months after randomization to the date of the death from any cause or to the last date of contact for a surviving pt.
Results
Examined pts were 130 (59 in arm A and 71 in arm B) in cohort-2M, 111 (50 in arm A and 61 in arm B) in cohort-4M, and 90 (43 in arm A and 47 in arm B) in cohort-6M, respectively. In cohort-2M, the median survival time (MST) was 14.1 months (m) (95% CI, 11.7-16.6) in arm A and 12.6 m (9.9-15.9) in arm B with hazard ratio (HR) of 0.935 (0.641-1.635). The OS was 9.7% (3.2-20.5) in arm A and 17.9% (9.2-28.8) in arm B at 3-year. In cohort-4M, the MST was 13.1 m (10.3-18.8) in arm A and 11.5 m (8.4-15.1) in arm B with HR of 0.954 (0.629-1.448). The OS was 11.5% (3.8-24.0) in arm A and 21.2% (11.0-33.6) in arm B at 3-year. In cohort-6M, the MST was 13.8 m (9.8-22.1) in arm A and 10.9 m (6.6-16.6) in arm B with HR of 0.860 (0.535-1.383). The OS was 13.2% (4.3-27.0) in arm A and 26.0% (13.1-41.0) in arm B at 3-year.
Conclusions
Among pts having certain period of chemotherapy, there seem to be more long survivors in arm B than the arm A. Reduction surgery may still be promising if chemotherapy compliance after surgery could be improved.
Clinical trial identification
UMIN000001012, Feb 2008.
Editorial acknowledgement
Legal entity responsible for the study
Japan Clinical Oncology Group (JCOG).
Funding
The Ministry of Health, Labour and Welfare of Japan and the Korean Gastric Cancer Association.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
5203 - Novel fusion genes identified from matched primary and recurred breast cancers by RNA-sequencing
Presenter: Soojeong Choi
Session: Poster Display session 2
Resources:
Abstract
5873 - Association between PIK3CA mutation status and development of brain metastases in HR+/HER2- metastatic breast cancer
Presenter: Donna Fitzgerald
Session: Poster Display session 2
Resources:
Abstract
3588 - The role of AXL as mechanism of resistance to trastuzumab and a prognostic factor in breast cancer HER2 positive: a translational approach.
Presenter: Anna Adam-Artigues
Session: Poster Display session 2
Resources:
Abstract
5640 - Untargeted assessment of tumor fractions in plasma for monitoring and prognostication from metastatic breast cancer patients undergoing systemic treatment
Presenter: Marija Balic
Session: Poster Display session 2
Resources:
Abstract
2616 - Clinical application of mutational analysis in breast cancer patients: the relevance of PIK3CA analysis for precision medicine.
Presenter: Juan Miguel Cejalvo
Session: Poster Display session 2
Resources:
Abstract
3870 - A retrospective gene expression analysis of surgically-removed Breast Cancer Brain Metastasis (BCBM)
Presenter: Meritxell Mallafré-Larrosa
Session: Poster Display session 2
Resources:
Abstract
1240 - Endocrine therapy alone versus targeted combination strategy as first line treatment in elderly patients with hormone receptor-positive advanced breast cancer: meta-analysis of Phase II and III randomized clinical trials
Presenter: Claudia Omarini
Session: Poster Display session 2
Resources:
Abstract
5535 - Alpelisib (ALP) + fulvestrant (FUL) for patients with hormone receptor–positive (HR+), HER2− advanced breast cancer (ABC): management and time course of key adverse events of special interest (AESIs) in SOLAR-1
Presenter: Hope Rugo
Session: Poster Display session 2
Resources:
Abstract
3093 - Changes in Hormone-Receptor status in Luminal breast cancers between primary tumor and metastases: results of the observational cohort GIM-13 AMBRA Study
Presenter: Marina Cazzaniga
Session: Poster Display session 2
Resources:
Abstract
1378 - MONARCH 3: Updated time to chemotherapy and disease progression following abemaciclib plus aromatase inhibitor (AI) in HR+, HER2- advanced breast cancer (ABC)
Presenter: Miguel Martín
Session: Poster Display session 2
Resources:
Abstract